Clinical and Brain Functional MRI Effects of a Rehabilitative Training of Upper Limb Using Immersive Virtual Reality in People With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Letters amplitude
研究概览
简要总结
The aim of this study is to assess the effect of 8-week physiotherapy training using immersive virtual reality (VR-training) compared to a physiotherapy training performed in a real setting (RS-training) on handwriting and touch screen technology-based activities, brain functional activity and cognition in patients with Parkinson's disease (PD). Both groups will perform upper limb exercises focused at improving movement amplitude and speed during several activities such as writing and using touch screen-technology. Participants randomized to VR-training (N=20) will perform exercises under the augmented visual feedback induced by the VR aimed at stimulating movement amplitude and speed. Participants randomized to RS-training (N=20) will perform exercises in a real setting.
Before training, after training (8 weeks) and at 3-month follow-up (20 weeks), subjects with PD will undergo clinical evaluations (neurological, physiotherapy and neuropsychological) while taking their regular anti-parkinsonian drugs (on-medication state). MRI scans will be acquired at each time-point to assess brain activity reorganization during off state (MRI scans will be acquired at least 12 hours after the regular evening dopaminergic therapy administration to mitigate the pharmacological effects on neural activity). A sample of matched healthy subjects (N=30) will undergo clinical, physiotherapy, neuropsychological and MRI assessments only at study entry as a benchmark.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Physiotherapist, neurologists, neuropsychologists and radiologist assessing the patients are blinded to group allocation.
入排标准
- 年龄范围
- — 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Letters amplitude
时间窗: Baseline, after 8 weeks of training and after 3-month follow-up
Changes in letters amplitude during a repetitive handwriting task on a writing tablet. Higher amplitude reflects a better performance. Assessment during ON medication phase
次要结局
- Repetitive Prewriting task on tablet(Baseline, after 8 weeks of training and after 3-month follow-up)
- Brain functional changes during hand-tapping in a virtual reality setting(Baseline, after 8 weeks of training and after 3-month follow-up)
- Brain functional changes during hand-tapping in a real setting(Baseline, after 8 weeks of training and after 3-month follow-up)
- Systematic Screening of Handwriting Difficulties test (SOS)(Baseline, after 8 weeks of training and after 3-month follow-up)
- Systematic Screening of Handwriting Difficulties test (SOS) on a tablet(Baseline, after 8 weeks of training and after 3-month follow-up)
- Funnel task on tablet(Baseline, after 8 weeks of training and after 3-month follow-up)
- Velocity of swipe-slide finger movements on a screen(Baseline, after 8 weeks of training and after 3-month follow-up)
- Velocity of finger tapping movements on a screen(Baseline, after 8 weeks of training and after 3-month follow-up)
- Cambridge Neuropsychological Test Automated Battery (CANTAB)(Baseline, after 8 weeks of training and after 3-month follow-up)
- Hand tapping task(Baseline, after 8 weeks of training and after 3-month follow-up)
- Finger tapping task(Baseline, after 8 weeks of training and after 3-month follow-up)
- Rubber Hand Illusion paradigm(Baseline, after 8 weeks of training and after 3-month follow-up)
- Manual Ability Measure (MAM-36) questionnaire(Baseline, after 8 weeks of training and after 3-month follow-up)
- Parkinson's Disease Questionnaire (PDQ-39) score(Baseline, after 8 weeks of training and after 3-month follow-up)
- Purdue Pegboard Test (PPT)(Baseline, after 8 weeks of training and after 3-month follow-up)
研究者
Prof. Massimo Filippi
Professor
IRCCS San Raffaele